eCTD Module 3

CTD Module 3 is the section of the common technical document (CTD) regulatory submissions format that contains all the required quality information and data corresponding to the registration of a pharmaceutical product. The CTD Module 3, also referred to as ICH Module 3, includes requirements for presenting manufacturing, characterization, drug substance controls, stability characteristics, descriptions and compositions of pharmaceuticals, and other essential information. The M4Q (Monitoring for Quality) guidance provided by ICH (International Council on Harmonisation) is a best-practice standard for completing Module 3 documentation.

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Hundreds of companies around the world use MasterControl to automate core business processes and document management activities to promote collaboration, improve decision making, and accelerate time to market.

What You Need to Know about Electronic CTD Module 3 and other Modules

In preparing your regulatory submissions, keep in mind that the overarching goal of following the eCTD is to make your documents reviewer-friendly. Module 1 is specific to every ICH region, which means it’s technically not part of the eCTD because it’s not common to all regions. Modules 2 through 5 contain the CTD and applies to all regions.

Specifically, eCTD Module 3 contains the pharmaceutical quality documentation. It describes the format and organization of the chemical, pharmaceutical, and biological data relevant to the application. eCTD Module 3 includes the table of contents, body of data, and literature references. The ICH website has more information about eCTD Module 3 and other modules.

What You Need to Know About Organizing CTD Module 3

The CTD Module 3 format outlines the requisite section names and numbers necessary for organizing your drug product’s quality-related content. It’s best to follow an electronic checklist that encompasses all Module 3 requirements and have the list and associated documentation viewed, reviewed and collaborated on by appropriate employees as well as partners and suppliers. These approved personnel will be reviewing documentation from various locations, so the system should preferably be web-based or updated regularly. Quality documentation and data should also be “attached” to the appropriate drug product as most companies are working on getting multiple drugs registered at the same time.

Automated Document Control and Management: For a more effective document control and management, automate the entire lifecycle of your documents: distribution and routing, follow-up, escalation, and approval. MasterControl will streamline your documents-based processes and make it easier for all stakeholders to participate in those processes.

Efficiency in Repurposing Content: Even though the eCTD standard format has harmonized the submission process within the pharmaceutical industry, companies still need to repurpose and tailor content for every submission. When generating content for eCTD Module 3 and other modules, MasterControl’s industry best-practice templates will standardize every registration project regardless of the regional variables.

Transparent Product Registration Projects: With MasterControl Registrations for eCTD, users will be able to identify the countries and regions where each of your product is being registered. In a similar fashion, they will be able to see all your products up for approval in every geographic location.

Closer Collaboration of Stakeholders: Many companies use different systems for different departments or business units, making it hard to connect those teams for the purpose of collaboration. MasterControl can be integrated with existing systems to facilitate collaboration throughout your organization, including external consultants and vendors. The system provides a virtual collaboration workspace 24/7.

Effective Milestone Management: If you are still relying on spreadsheets to manage project milestones, it’s high time to switch to a fully automated system. MasterControl will provide your organization with robust project management tools (dashboards, checklists, and analytics) to show all product registrations associated with every document and vice versa.

Integrated Platform: Many pharmaceutical companies worldwide use MasterControl as their compliance platform, integrating disparate systems and connecting their stakeholders. It provides a single, centralized repository for all submission artifacts.

The QMS Provider for the FDA

MasterControl Inc. and its partner, i4DM, are expanding their FDA project, serving as the QMS providers for a second FDA division. The two companies have been the QMS providers for the FDA's Office of Regulatory Affairs since 2009. Now they will also serve as quality providers for the Division of Pharmaceutical Analysis, which is part of the FDA's Center for Drug Evaluation and Research.